Tympanic Thermometers Accuracy

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Fever

Treatments: Diagnostic Test: latest generation tympanic thermometer

Study type: Observational

Funder types: Other

Identifiers

NCT06103604

507/2023/Oss/IOR

Details and patient eligibility

About

The aim of the present study is to evaluate the measurement precision and accuracy of the third-generation tympanic thermometer in relation to the measurement modalities considered gold standard. The evaluation of the instrument will be conducted in relation to the different calibration times of the tympanic thermometer, the level of re-training of healthcare personnel in the use of the instrument and the adult and paediatric population subjected to the measurement. Finally, the diagnostic capacity of the instrument in correctly identifying states of hypothermia and febrile elevations will be assessed.

Full description

The temperature measurement will be taken on each patient enrolled at a single time by the caregiver for that patient. As the measurements do not depend on which side they are taken, the most convenient side will be chosen. Each patient will only be included once

The research nurse will record the core temperature from the monitor on the CRF and, within the next 5 minutes, take the peripheral temperature with the tympanic thermometer three times in a row, recording all three values on the CRF. Subsequently a second operator will always take the temperature 3 times within 5 minutes of the gold standard measurement. The gold standard (reference tests), as indicated in the literature, can be either the thermometer inserted in the probe placed in the pulmonary artery, or the thermometer inserted in the bladder catheter or oesophageal probe, or directly a rectal thermometer.

Only the first tympanic measurement will then be used to assess accuracy against the gold standard. The other measurements above will only be evaluated for inter and intra reliability. The unit under study is therefore the individual patient at a precise point in time

Enrollment: 1,100 patients

Sex: All

Ages: 4+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Paediatric patients over the age of 4 months
• adults admitted to intensive care and resuscitation
• undergoing surgery who by current practice undergo invasive core temperature measurement

Exclusion criteria

• Patients with bilateral auricular inflammatory problems,
• patients who will not use the gold standard for clinical reasons,
• patients or legal guardians who do not consent to participate in the study.

Trial design

1,100 participants in 1 patient group

in-patients requiring temperature monitoring

Description:

The patient at any age whose core temperature is monitored during hospitalisation

Treatment:

Diagnostic Test: latest generation tympanic thermometer